Abbott’s Covid-19 antigen test gets FDA authorisation for asymptomatic use

1 April 2021 (Last Updated April 1st, 2021 12:43)

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Abbott’s BinaxNOW COVID-19 Ag Self Test for over the counter, non-prescription, asymptomatic use. 

Abbott’s Covid-19 antigen test gets FDA authorisation for asymptomatic use
A mother swabs her son’s nostril using a shallow nasal swab before conducting an Abbott BinaxNOW COVID-19 Self Test. Credit: Abbott.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Abbott’s BinaxNOW COVID-19 Ag Self Test for over the counter, non-prescription, asymptomatic use.

The lateral flow immunoassay is intended for the qualitative identification of nucleocapsid protein antigen from SARS-CoV-2 in just 15 minutes.

It is authorised for home use with self-collected observed direct anterior nasal (nares) swab specimens from people aged 15 years or above or adult-collected nasal swab samples from children aged two years or above.

The rapid antigen test can be used for testing people with or without symptoms or other epidemiological reasons to suspect Covid-19 when tested twice over three days with a gap of at least 36 hours.

The test comes in a two-count box for meeting serial testing needs and does not require a prescription. The swab, test card and reagent solution needed to carry out the test will all be provided in the box.

Abbott president and CEO Robert Ford said: “We’ve now accomplished what we set out to do when we launched BinaxNOW, which is to bring an accurate, affordable and readily available test to the American people that they can have on hand, whether they want to test frequently or in certain circumstances.”

“Together with vaccines, the BinaxNOW Self Test will help Americans get back to doing what they want and need to do – like going to work and school or seeing friends and family – with greater confidence.”

In January, Abbott received a CE Mark for its Panbio COVID-19 Ag Rapid Test Device to detect SARS-CoV-2 virus for two new uses of asymptomatic testing and self-swabbing.

In a separate development, the Biomedical Advanced Research and Development Authority (BARDA) and the US Department of Defense have awarded an undefinitised contract worth $53.7m to Ortho Clinical Diagnostics to develop its Covid-19 serological and diagnostic testing solutions.

The contract will aid in a more than three-fold increase in domestic production capabilities for the testing solutions.